Most of the current nuclear medicine diagnostic procedures use a radioisotope. An illustrative, but nonlimiting, example of a radioisotope includes technetium (Tc-99m). The radioactive technetium, obtained from a generator located in a radio-pharmacy, is dissolved in a saline solution and is placed in an eluate vial which is surrounded by a lead eluate shield or pig. The activity level of this technetium is high (approximately 100 to 1,000 mCi/mL at time of preparation) and is often diluted before it is used. The radiopharmacy can prepare multi-dose vials of technetium and saline and/or ready-to-use kits that include: (a) technetium; (b) saline; and (c) lyophilized reagents. The multi-dose vials of technetium are also sold to hospitals and other medical facilities. The hospitals may use the technetium from the multi-dose vial to administer to a patient or to prepare their own lyophilized reagent kits. The multi-dose vials have an activity level that varies from 10–200 mCi/mL at time of preparation.
The ready-to-use kits include lyophilized reagents, which do not contain radioactive material, are the product of the “cold” production line. The lyophilized reagents have been formulated to collect at specific locations in the body such as the heart, bones or kidneys. The radioactive kits are prepared by mixing technetium and saline with the lyophilized reagents at the radiopharmacies. Most of these “prepared” kits contain several individual doses and have an activity level that varies widely depending on the type of radiopharmaceutical prescribed. The activity level in a “prepared kit” may range from 10 to 200 mCi/mL at the time of preparation.
Currently kits and multi-dose vials of radioisotopes, e.g., technetium, are filled by hand by a pharmacist and/or their technician at the radiopharmacy. This will lead to extremity exposure for the personnel during handling the radioactive materials (e.g., transferring liquid from one vial to another with the use of a syringe in a syringe shield). These pharmacists and technicians are required to wear extremity dosimeters and must comply with annual radiation exposure limits. If their cumulative radiation exposure limit nears their annual limit, the pharmacist or technician is restricted from the lab and must work elsewhere in the radiopharmacy. This will increase the manpower demands at the radiopharmacy and could potentially increase the level of radiation exposure for remaining pharmacists and technicians.